Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Aug 2, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect early signs of heart damage caused by radiation therapy in patients with left-sided breast cancer and other thoracic cancers. The researchers want to see if they can identify changes in how the heart's energy-producing parts, called mitochondria, work after patients receive standard radiation treatment. By looking for these early changes, the study hopes to find a way to monitor heart health during cancer treatment.

To participate in this trial, patients should have a tumor in the left breast or thorax and be eligible for radiation therapy. They must be between the ages of 65 to 74 and able to understand and sign consent forms. Participants will receive standard radiation therapy and undergo specific imaging tests to monitor their heart function. It’s important to note that women who can become pregnant and men must agree to use contraception during the study to ensure safety. Overall, this trial aims to improve how we detect and manage heart health in cancer patients undergoing radiation therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Benign or malignant tumor of the breast (left-sided only) or thorax
• • 2. Stage I to IV. If stage IV, patient must have life expectancy equal to or greater than 6 months
• • 3. ECOG performance status 0-1
• • 4. The patient must be deemed an appropriate candidate for standard of care radiation therapy
• • 5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• • Has not undergone a hysterectomy or bilateral oophorectomy; or
• • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• 5.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria:
• • s/p bilateral oophorectomy, OR
• • with intact uterus without menses in the past 12 months OR,
• • with biochemical confirmation of post-menopausal status (estradiol in the menopausal range based on local laboratory criteria)
• • 6. Ability to understand and the willingness to sign a written informed consent.
• Exclusion Criteria:
• • 1. Prior radiation involving the heart
• • 2. Subjects may not be receiving any known cardiotoxic agents for the 6 months prior to the study and during the study
• • 3. Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis
• • 4. Patients with stage IV cancer with life expectancy of less than 6 months
• • 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• • 6. eGFR \<30
• • 7. Any contraindication to MRI (including, but not limited to metal implants and devices contraindicated at 3T, breast tissue expanders, non-MR compatible IV port, claustrophobia)
• • 8. History of psychiatric or addictive disorders that would preclude obtaining informed consent
• • 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.